The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Volara system with in-line ventilator adaptor (OPTIMUS Handset 2) or Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit) Product Model Numbers: PVLIHCBA, M08594,…
Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
Summary Company Announcement Date: June 22, 2022 FDA Publish Date: June 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination with Gluconacetobacter liquefaciens Company Name: Vi-Jon, LLC Brand Name: Brand Name(s) CVS Health Product Description: Product Description Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor Company Announcement June 21, 2022 –…
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)
Date Issued: May 7, 2019 Audience: Patients with a Medtronic pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) Caregivers of patients with a Medtronic pacemaker or CRT-P Cardiologists, electrophysiologists, cardiac surgeons, and primary care physicians treating patients with heart failure or heart rhythm problems using a Medtronic pacemaker or CRT-P Medical Specialties: Cardiac Electrophysiology, Cardiology, Cardiothoracic…
Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone
Summary Company Announcement Date: June 10, 2022 FDA Publish Date: June 14, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Diclofenac and Dexamethasone Company Name: Latin Foods Market Brand Name: Brand Name(s) Product Description: Product Description Artri King Reforzado con Ortiga y Omega 3 Company Announcement Latin Foods Market is voluntarily recalling…
Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients
Summary Company Announcement Date: May 28, 2022 FDA Publish Date: May 28, 2022 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Contains diclofenac Company Name: Walmart Inc. Brand Name: Brand Name(s) Artri Ajo King Product Description: Product Description Joint supplements Company Announcement Walmart Inc. is voluntarily recalling all lots of Artri Ajo King…
Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination
Summary Company Announcement Date: June 09, 2022 FDA Publish Date: June 09, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial contamination identified as Providencia rettgeri. Company Name: Green Pharmaceuticals Inc Brand Name: Brand Name(s) Product Description: Product Description Nasal spray Company Announcement FOR IMMEDIATE RELEASE – June 09, 2022 –…
Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: HVAD Pump Implant Kit Models: 1101, 1103, 1104, 1104JP, MCS1705PU Distribution Dates: October 11, 2006 to June 3, 2021 Devices Recalled in the U.S.: 1,614…
Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
Summary Company Announcement Date: June 08, 2022 FDA Publish Date: June 08, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial contamination Company Name: Plastikon Healthcare, LLC Brand Name: Brand Name(s) Plastikon Healthcare, LLC Product Description: Product Description Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension Company Announcement FOR IMMEDIATE RELEASE…
Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination
Summary Company Announcement Date: June 07, 2022 FDA Publish Date: June 07, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains elevated levels of Bacillus cereus Company Name: Buzzagogo Inc. Brand Name: Brand Name(s) Allergy Bee Gone for Kids Product Description: Product Description Nasal Swab Remedy Company Announcement FOR IMMEDIATE RELEASE –…
Ukoniq (umbralisib): Drug Safety Communication – FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns
[Posted 06/01/2022] AUDIENCE: Oncology, Patient, Health Professional, Pharmacy ISSUE: Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, the FDA determined the risks of treatment with Ukoniq…